Software development can teach us a lot about streamlining the research and development (R&D) process in other industries. “Agile development”, or the process of dividing up an R&D project into smaller, more iterative segments instead of planning the entire project at its inception, is a hallmark of the software development process. In a recently published
EHR Interoperability: Public Health Benefits & Privacy Considerations
Public-health researchers, officials and medical professionals rely on data to track outbreaks, advance research, and evaluate prospective treatments. One critical source of patient data comes from electronic health records (EHRs). EHR data in the U.S. has traditionally been siloed within hospital IT systems, but the federal government and key healthcare stakeholders have recently ramped up
State Medical Licensing Changes to Combat COVID-19
The rapid spread of COVID-19 has transitioned the telehealth debate from a matter of access, convenience, and cost-saving to a matter of absolute necessity on a large scale. A variety of barriers have traditionally stood in the way of broader adoption of telehealth including a lack of reimbursement by both state and private insurance, restrictions
The Potential Benefits of Digital Health Technology in Managing COVID-19
The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges. The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19. The Centers for Disease Control
Ideation Question #3: Who Will Supply the Data?
This is the third of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the data used in the offering?
Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.” FDA opened a docket for public comments on the Framework through February 5, 2019.
The Framework focuses in particular on the use of RWE to support regulatory decisions about effectiveness. The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications. The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs. This blog post provides an overview of FDA’s proposal and highlights a few initial takeaways noted by Covington’s Digital Health team.
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What physicians are reading about digital health
There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions. These papers serve as examples of the active dialogue taking place around the appropriate regulatory
Open Source Considerations for Digital Health Ventures
Technology companies widely use open source software (“OSS”), which carries with it many potential benefits. It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs. OSS can also reduce dependency upon third party vendors and associated pricing risks.
In the healthcare space in particular, OSS has been cited as one potential way to reduce the cost of developing and delivering digital care solutions, which in turn may mean improved access to or quality of treatment for underserved populations.[1] And indeed, OSS is frequently used in healthcare IT. In fact, the EHR system for veterans, VistA, is available as open source code[2] and now deployed by a range of healthcare organizations.[3]
Of course, as with any third party technology, when incorporating OSS into a technology, it is important to carefully consider the soundness and security of the OSS code, as well as the legal terms on which the code is made available. Below we highlight some key considerations for digital health ventures that either currently do or wish to use OSS for their technology: (1) security, (2) how license terms may impact the ability to commercialize the technology, and (3) how the use of OSS may impact corporate transactions, such as mergers and acquisitions.
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Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions
In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.
Key Commercial Questions When
Contracting for Digital
Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)
In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.
Key Regulatory Questions About Digital Health Solutions
1. What